Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
TELA Bio, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243595 | OviTex PRS (Long-Term Resorbable) | TELA Bio, Inc. | 2024-12-19 | 29 | 0 |
| K241126 | OviTex PRS | TELA Bio, Inc. | 2024-05-22 | 29 | 0 |
| K141053 | OVINE TISSUE MATRIX(OTM) | TELA Bio, Inc. | 2014-12-11 | 231 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda